TB Study Lights Pathway Toward Combination Drug Trial Guidance
A clinical trial of three new tuberculosis drugs, along with one that is used in standard therapy, exemplifies FDA's evolving approach to studies that combine more than one investigational drug.
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CDER’s Janet Woodcock says the community has the agency’s ear when it advocates new developments; cites need for an “adult conversation” in assessing when drugs should be made available to patients.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.
Important safety questions remain for what could be the first new tuberculosis drug in 40 years, and there was a lack of efficacy in the key subgroup of black patients.